Trials / Unknown
UnknownNCT04502017
Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.
Detailed description
Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes 6-weeks of warfarin + aspirin followed by dual anti platelet therapy with clopidogrel (75 mg) and aspirin (81-325 mg) until 6 months of follow-up, then aspirin alone is continued indefinitely. Nonetheless, a significant number of patients continues to suffer from device-related thrombosis which carries a high risk of thromboembolic events. Other AT strategies have been tested in order to reduce the risk of thrombus-formation on device. Among them, replacement of clopidogrel with half-dose oral anticoagulation (OAC) in patients with genetic resistance to this drug has been recently reported to reduce the incidence of DRT. Additionally, reduced dose of novel OAC was demonstrated to lead to lower thrombin generation compared to DAPT.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ASA plus Clopidogrel | OAC (6 weeks) + DAPT (until 6 months) + ASA |
| DRUG | Genetic-Tailored AntiThrombotic Strategy | Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype |
| DRUG | Half-Dose of novel OAC | Half Dose of novel OAC post-device Implantation |
Timeline
- Start date
- 2020-08-05
- Primary completion
- 2022-12-31
- Completion
- 2023-12-31
- First posted
- 2020-08-06
- Last updated
- 2020-08-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04502017. Inclusion in this directory is not an endorsement.